MyelofibrosisPhase 3POIESISNCT06479135
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
A Phase 3 study testing Navtemadlin and Ruxolitinib in people with Myelofibrosis and Post-PV MF, run by Kartos Therapeutics, Inc. at 215 sites in 19 countries.
Trial summary
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis
- What is being tested?
- Navtemadlin and Ruxolitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 215 sitesin 19 countries
- Study dates
- 3 Jun 2024to 31 Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria
- High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- JAK-inhibitor treatment naive
- PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing
- ECOG performance status of 0 to 2
- Treatment with a stable dose of ruxolitinib
- Suboptimal response to run-in ruxolitinib treatment
Who cannot join
- Prior Splenectomy
- Splenic irradiation within 3 months prior to the first dose
- Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53-directed therapy
- Eligible for Bone Marrow Transplant
- Peripheral blood or bone marrow blast count ≥ 10 percent
- Elevated white blood cell count that doubles (or more) during ruxolitinib treatment and exceeds 50 × 10^9/L
- Peripheral blood or bone marrow blast count ≥ 10 percent
Trial locations and contacts
215 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
215 sites in 19 countries
United States58 sites, 58 recruiting
- Recruiting
University of Michigan Hospital
Ann Arbor, Michigan, 48109
- Recruiting
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80012
- Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
- Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
- Recruiting
The Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
- Recruiting
UAB Hospital
Birmingham, Alabama, 35233
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
- Recruiting
Gabrail Cancer Center
Canton, Ohio, 44718
- Recruiting
Medical University of South Carolina (MUSC)
Charleston, North Carolina, 29425-8900
- Recruiting
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28204
- Recruiting
Tennessee Oncology
Chattanooga, Tennessee, 37404
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Recruiting
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, 44111
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
UT - SouthWestern
Dallas, Texas, 75390
- Recruiting
Mission Cancer + Blood
Des Moines, Iowa, 50314
- Recruiting
Henry Ford Cancer Institute - Brigitte Harris Cancer Pavilion
Detroit, Michigan, 48202
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
Mohtaseb Cancer Center and Blood Disorders
Henderson, Nevada, 86442
- Recruiting
U.T. MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Independence Family Health Center - Cleveland Clinic
Independence, Ohio, 44131
- Recruiting
Cayuga Cancer Center
Ithaca, New York, 14850
- Recruiting
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92037
- Recruiting
Northwell Health, R.J. Zuckerberg Cancer Center
Lake Success, New York, 11042
- Recruiting
Nebraska Hematology - Oncology, P.C.
Lincoln, Nebraska, 68506
- Recruiting
UCLA Hematology/Oncology Clinic - Los Angeles
Los Angeles, California, 90095
- Recruiting
Norton Cancer Institute
Louisville, Kentucky, 40207
- Recruiting
Hillcrest Hospital - Cleveland Clinic
Mayfield Heights, Ohio, 44124
- Recruiting
University of Miami
Miami, Florida, 33136
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Recruiting
ICAHN School of Medicine at Mount Sinai
New York, New York, 10029-6574
- Recruiting
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713
- Recruiting
AdventHealth Cancer Institute
Orlando, Florida, 32803
- Recruiting
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
- Recruiting
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
- Recruiting
Virginia Cancer Institute
Richmond, Virginia, 23229
- Recruiting
VCU Medical Center
Richmond, Virginia, 23298
- Recruiting
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Recruiting
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
- Recruiting
Scripps Health, Prebys Cancer Center
San Diego, California, 92103
- Recruiting
Fred Hutchinson Cancer Centre
Seattle, Washington, 98109
- Recruiting
Sheboygan Cancer & Blood Specialists
Sheboygan, Wisconsin, 53081
- Recruiting
Northwest Medical Specialties, PLLC - Tacoma
Tacoma, Washington, 98405
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
- Recruiting
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10467
- Recruiting
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
- Recruiting
Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia, 23456
- Recruiting
MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
- Recruiting
University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
- Recruiting
Regional Medical Oncology Center
Wilson, North Carolina, 27893
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Italy18 sites, 18 recruiting
- Recruiting
National Hospital SS. Antonio e Biagio e Cesare Arrigo
Alessandria
- Recruiting
Marche University Hospital
Ancona, 60126
- Recruiting
Polyclinic S. Orsola-Malpighi
Bologna, 40138
- Recruiting
ASST Spedali Civili Brescia
Brescia
- Recruiting
University Hospital "G.Rodolico - San Marco"
Catania
- Recruiting
Careggi University Hospital
Florence, 50134
- Recruiting
Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST
Forlì, 47014
- Recruiting
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, 20122
- Recruiting
European Institute of Oncology (IEO), IRCCS
Milan
- Recruiting
University Hospital "Maggiore della Carita" of Novara
Novara, 28100
- Recruiting
University Hospital San Luigi Gonzaga
Orbassano
- Recruiting
University Polyclinic Hospital "Paolo Giaccone" Palermo
Palermo
- Recruiting
Polyclinic San Matteo, IRCCS
Pavia
- Recruiting
Local Health Company of Pesaro and Urbino
Pesaro, 61121
- Recruiting
Hospital Arcispedale S. Maria Nuova of Reggio Emilia
Reggio Emilia
- Recruiting
Hospital S. Eugenio- Rome 2 ASL
Rome
- Recruiting
City of Health and Science of Turin
Turin, 10126
- Recruiting
ASST Sette Laghi Hospital
Varese
France14 sites, 14 recruiting
- Recruiting
Amiens Picardie University Hospital - South
Amiens, 59037
- Recruiting
Angers University Hospital Center
Angers
- Recruiting
Lille Regional University Hospital Center
Lille, 59037
- Recruiting
South Lyon Hospital Center
Lyon, 69310
- Recruiting
Leon Berard Center
Lyon
- Recruiting
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, 44000
- Recruiting
Archet 1 and 2 hospital
Nice, 06200
- Recruiting
Nimes University Hospital Center, Department of Clinical Hematology and Medical Oncology
Nîmes, 30900
- Recruiting
Saint-Louis Hospital, Department of Adult Hematology
Paris, Paris, 75010
- Recruiting
Bordeaux University Hospital
Pessac
- Recruiting
University Hospital Center of Poitiers
Poitiers
- Recruiting
Strasbourg Europe Institut of Cancerology
Strasbourg, 67200
- Recruiting
University Hospital of Toulouse, IUCT-Oncopole
Toulouse
- Recruiting
Tours Regional University Hospital Center
Tours, 37000
Germany14 sites, 14 recruiting
- Recruiting
Marien Hospital Duesseldorf GmbH
Düsseldorf, 40479
- Recruiting
University Hospital Freiburg
Freiburg im Breisgau, 79106
- Recruiting
University Hospital Halle (Saale)
Halle, 06120
- Recruiting
University Hospital Hamburg-Eppendorf
Hamburg, 20246
- Recruiting
Hannover Medical School
Hanover
- Recruiting
University Hospital Heidelberg
Heidelberg, 69120
- Recruiting
University Hospital Jena
Jena, 07747
- Recruiting
University Hospital Schleswig-Holstein
Kiel, 24105
- Recruiting
MVZ Mitte Am Johannisplatz
Leipzig, 04103
- Recruiting
Hospital Rechts der Isar
Munich, 81675
- Recruiting
Staufer Schwaebisch Gmuend Hospital
Mutlangen, 73557
- Recruiting
Hospital Nuernberg, Campus North
Nuremberg, 90419
- Recruiting
Robert-Bosch-Hospital
Stuttgart, 70376
- Recruiting
University Hospital Ulm
Ulm, 89081
United Kingdom14 sites, 14 recruiting
- Recruiting
Birmingham Heartlands Hospital
Birmingham, B9 5SS
- Recruiting
Lincoln County Hospital
Boston, Lincoln County Hospital
- Recruiting
Pilgrim Hospital
Boston, PE21 9QS
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
- Recruiting
University Hospital of Wales
Cardiff, CF14 4XW
- Recruiting
Western General Hospital, Lothian Health Board
Edinburgh, EH4 2XU
- Recruiting
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
- Recruiting
Harrogate District Hospital
Harrogate, HG2 7SX
- Recruiting
Leicester Royal Infirmary
Leicester, LE1 5WW
- Recruiting
The Clatterbridge Cancer Center NHS Foundation Trust
Liverpool, L7 8YA
- Recruiting
University College Hospital
London, NW1 2PG
- Recruiting
Guy's Hospital
London, SE1 9RT
- Recruiting
Genesis Care, Oxford
Oxford, OX4 6LB
- Recruiting
Genesis Care, Windsor
Windsor, SL4 3HD
Poland12 sites, 12 recruiting
- Recruiting
"InterHem" General Partnership
Bialystok
- Recruiting
University Teaching Centre, Hematology and Transplantology Clinic
Gdansk
- Recruiting
Independent Public Healthcare Facility University Hospital in Krakow
Krakow
- Recruiting
Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center
Lodz, 93-513
- Recruiting
Jedrzej Sniadecki Specialist Hospital in Nowy Sacz
Nowy Sącz, 33 - 300
- Recruiting
Oncology Center of Warmia and Mazury in Olsztyn
Olsztyn
- Recruiting
AIDPORT
Poznan, 60-185
- Recruiting
Janusz Korczak Provincial Specialist Hospital
Słupsk, 76-200
- Recruiting
Dom Lekarski Medical Center Outlet Park
Szczecin, 70-784
- Recruiting
Dr Alfred Sokolowski Specialty Hospital
Wałbrzych
- Recruiting
Clinical Best Solutions LLC, Limited Partnership
Warsaw, 00-710
- Recruiting
Jan Mikulicz-Radecki Teaching Hospital in Wroclaw
Wroclaw
Spain12 sites, 11 recruiting
- Recruiting
University Hospital Germans Trias i Pujol
Badalona, 08916
- Recruiting
University Hospital Vall d'Hebron
Barcelona, 08035
- Recruiting
Catalan Institute of Oncology, Hospital Duran i Reynals
Barcelona
- Withdrawn
Caceres Hospital Complex - San Pedro de Alcantara General Hospital
Cáceres, 10003
- Recruiting
Gran Canaria Dr Negrin University Hospital
Las Palmas de Gran Canaria, 35010
- Recruiting
University Hospital 12 de Octubre
Madrid, 28041
- Recruiting
University Hospital Ramon y Cajal
Madrid, 28041
- Recruiting
University Hospital Virgen de la Victoria
Málaga, 29010
- Recruiting
University Clinical Hospital of Salamanca
Salamanca, 37007
- Recruiting
University Clinical Hospital of Valencia
Valencia, 46010
- Recruiting
University and Polytechnic Hospital La Fe
Valencia, 46026
- Recruiting
Quironsalud Zaragoza Hospital
Zaragoza, 50006
Australia11 sites, 11 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, SA 5000
- Recruiting
Monash Medical Center Clayton
Clayton, VIC 3168
- Recruiting
Townsville University Hospital
Douglas, QLD 4814
- Recruiting
Gosford Hospital
Gosford, NSW 2250
- Recruiting
Royal Hobart Hospital (RHH)
Hobart, Tasmania, 7000
- Recruiting
St George Hospital
Kogarah, NSW 2217
- Recruiting
The Royal Melbourne Hospital - Peter MacCallum Cancer Center
Melbourne, VIC 3000
- Recruiting
The Alfred Hospital
Melbourne, VIC 3004
- Recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
- Recruiting
Royal Perth Hospital
Perth, 6000
- Recruiting
Calvary Mater Newcastle Hospital
Waratah, NSW 2298
South Korea9 sites, 9 recruiting
- Recruiting
Inje University Busan Paik Hospital
Busan, 47392
- Recruiting
Pusan National University Hospital
Busan, 49241
- Recruiting
Kyungpook National University Hospital
Daegu, 41944
- Recruiting
Keimyung University - Dongsan Medical Center
Daegu, 42601
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Soon Chun Hyang University Hospital Seoul
Seoul, 04401
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Austria7 sites, 7 recruiting
- Recruiting
University Hospital Graz, Department of Internal Medicine
Graz, 8036
- Recruiting
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
Innsbruck, 6020
- Recruiting
Regional Hospital Hochsteiermark - Leoben, Department of Internal Medicine, Department of Hematology and Oncology
Leoben, 8700
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen Hospital, Department of Internal Medicine I - Hemato-Oncology
Linz, 4020
- Recruiting
Kepler University Hospital GmbH, Med Campus 3, University Clinic for Hematology and Internal Oncology
Linz, 4021
- Recruiting
Medical University Vienna
Vienna, 1090
- Recruiting
Hospital Ottakring, Department of Internal Medicine I
Vienna, 1160
Croatia7 sites, 7 recruiting
- Recruiting
Clinical Hospital Centre Rijeka
Rijeka, 51 000
- Recruiting
General Hospital of Sibenik-Knin County
Šibenik, 22000
- Recruiting
University Hospital of Split
Split, 21000
- Recruiting
Clinical Hospital Dubrava
Zagreb, 10000
- Recruiting
Clinical Hospital Merkur
Zagreb, 10000
- Recruiting
Solmed Clinic
Zagreb, 10000
- Recruiting
University Hospital Centre Zagreb
Zagreb, 10000
Georgia6 sites, 6 recruiting
- Recruiting
JSC Vian
Kutaisi, 4600
- Recruiting
JSC German Hospital
Tbilisi, 0119
- Recruiting
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 0141
- Recruiting
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
Tbilisi, 0144
- Recruiting
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 0159
- Recruiting
Caucasus Medical Centre LLC
Tbilisi, 0186
Belgium5 sites, 5 recruiting
- Recruiting
Antwerp Hospital Network (ZNA) Cadix
Antwerp, 2030
- Recruiting
University Hospitals Leuven, Campus Gasthuisberg
Leuven, 3000
- Recruiting
University Hospital Center Sart-Tilman
Liège, 4000
- Recruiting
General Hospital Delta
Roeselare, 8800
- Recruiting
UCL Mont-Godinne University Hospitals
Yvoir, 5530
Czechia5 sites, 5 recruiting
- Recruiting
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
Brno, 625 00
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, 500 05
- Recruiting
University Hospital Ostrava
Ostrava, 708 52
- Recruiting
University Hospital Kralovske Vinohrady
Prague, 100 00
- Recruiting
Institute of Hematology and Blood Transfusion
Prague, 12800
Greece5 sites, 5 recruiting
- Recruiting
General Hospital of Athens Laikon
Athens, 115 27
- Recruiting
University General Hospital "Attikon"
Athens, PC 12462
- Recruiting
University General Hospital of Ioannina
Ioannina
- Recruiting
University General Hospital of Patras
Pátrai, 26504
- Recruiting
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, PC 57010
Portugal5 sites, 5 recruiting
- Recruiting
Hospital Center of Baixo Vouga -Aveiro Unit - Hospital Infante D. Pedro
Aveiro, 3810- 501
- Recruiting
Braga Hospital
Braga
- Recruiting
Central Hospital of Western Lisbon
Lisbon, 1449-005
- Recruiting
Centro Hospitalar Lisboa Norte (CHLN) EPE - Hospital de Santa Maria
Lisbon, 1649-035
- Recruiting
Vila Nova de Gaia Central Hospital
Vila Nova de Gaia
Romania5 sites, 5 recruiting
- Recruiting
Onco Card Srl
Brasov, 500052
- Recruiting
Colentina Clinical Hospital, Department of Hematology
Bucharest, 020125
- Recruiting
"Prof. Dr. Ion Chiricuta" Institute of Oncology, Hematology Department
Cluj-Napoca, 400015
- Recruiting
Bihor County Emergency Clinical Hospital, Department of Hematology
Oradea, 410469
- Recruiting
Targu Mures County Emergency Clinical Hospital, Internal Medicine Department I, Hematology Unit
Târgu Mureş, 540136
Hungary4 sites, 4 recruiting
- Recruiting
Semmelweis University
Budapest, H-1088
- Recruiting
Szabolcs-Szatmar-Bereg County Teaching Hospital
Nyíregyháza, 4400
- Recruiting
Fejer County St. Gyorgy University Teaching Hospital
Székesfehérvár
- Recruiting
Tolna County Hospital
Szekszárd, H-7100
Serbia4 sites, 4 recruiting
- Recruiting
University Clinical Center of Serbia
Belgrade, 11000
- Recruiting
Clinical Hospital Center Bezanijska Kosa
Belgrade, 7203
- Recruiting
University Clinical Center Kragujevac
Kragujevac, 34 000
- Recruiting
Clinical Center of Vojvodina
Novi Sad
About this study
Official title: A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.
Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.
- Conditions
- Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis, Primary Myelofibrosis, MF
- Being tested
- Navtemadlin, Navtemadlin placebo, Ruxolitinib
- Keywords
- Navtemadlin, KRT-232, Ruxolitinib, POIESIS, TP53, Suboptimal response, Sub-optimal response
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavtemadlinDrug
Also called KRT-232
Navtemadlin is an investigational MDM2 inhibitor
Navtemadlin placeboDrug
Also called KRT-232
Navtemadlin placebo
RuxolitinibDrug
Also called Jakafi, Jakavi
Ruxolitinib is a janus kinase 1/2 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Navtemadlin administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day. Receives: Drug: Navtemadlin; Drug: Ruxolitinib |
| Arm 2 | Active comparator | Navtemadlin placebo administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day. Receives: Drug: Navtemadlin placebo; Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare spleen volume reduction (SVR35) between Arm 1 and Arm 2
The proportion of subjects in each arm with SVR35 by MRI/CT scan (central review) 24 weeks after start of the randomized period
Measured: 24 weeks
To compare total symptom score reduction (TSS50) between Arm 1 and Arm 2
The proportion of subjects in each arm with a TSS50 by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 24 weeks after start of the randomized period
Measured: 24 weeks
Secondary outcomes (2)
To compare time to progression between Arm 1 and Arm 2
Time to progression or death from any cause in subjects randomized to each arm
Measured: Up to 8 years
To compare overall survival (OS) between Arm 1 and Arm 2
Time to death from any cause in subjects randomized to each arm
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start3 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kartos Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479135
- Sponsor's protocol ID
- KRT-232-115
- Acronym
- POIESIS
- Status last verified
- Oct 2024
- First submitted
- 21 Jun 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No